Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Title: Data Entry Operator III
Location: Portsmouth, NH, 03801
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift: (Tuesday-Saturday) or (Sunday-Thursday)
Job Description:
The Data Entry Specialist's primary responsibility is transcribing data into Global Data Mart (GDM).
The DE Specialist will support the MSAT Team, the Process Analytics Team, the Process Validation Team and Investigation teams thereby supporting the critical successive steps essential to the client's local as well global manufacturing operations.
The Data Entry Specialist focus is to locate, collect, manually enter and verify batch record data.
The Data Entry Specialist must ensure data integrity as well as timely data availability to internal and external data consumers.
A Data Entry Specialist will work with the Manufacturing Teams to understand the process, its flow and unique steps such that he/she can manually transcribe and verify the data which characterizes and defines the process itself in accordance with cGMP
80% - Enter and verify large amounts of information accurately and consistently from process Batch Records
Manage and Track workload, ensure all necessary process data is located entered
Develop and utilize existing tools to examine, manage and track workload
Provide timely and accurate entry of process data in support of daily process monitoring and associated activities
Manage special requests for data collection, completion and/or verification
Help to Ensure all data entry system procedures and guidelines are accurate and curren
Ensure 100% accuracy of all information entered, right first time
5% - Understand Basic Processing and Analytics
Will develop and understanding of the relationship between data collection and process monitoring
Will develop understanding of basic manufacturing process technologies, terminologies and analysis tools
Will develop an understanding of the Statistica Enterprise Architecture such that this knowledge can be applied to creation and maintenance of data collection systems
5% - Interaction and user support for data consumption and analytics
Routinely interact with data consumers, help to create necessary efficiencies
Work to build user confidence in the system
Observe how the client users interact with GDM, understand their needs provide support as required
Resolve data entry related analytics problems with users
10% - Training:
Follows all training and policy guidelines established for the facility as well as all cGMP requirements.
Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. Compliance Wire, SAP Learning Portal) and completing all training in a timely fashion.
Perform other duties as assigned.
High School Diploma or Equivalent
0-3 years of biotech industry as well as relevant data collection systems exposure preferred
Solid computer skills including Microsoft Office a must
Detail oriented, Self-motivated, able to work independently.
TekWissen Group is an equal opportunity employer supporting workforce diversity.